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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR ZEGERID OTC

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505(b)(2) Clinical Trials for Zegerid Otc

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT01077076 Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED) Completed Bayer Phase 3 2008-12-01 This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to: 1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments; 2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing. 3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Zegerid Otc

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00557349 Ulcer Prevention Study in Post Gastric Bypass Patients Unknown status University of Missouri-Columbia Phase 4 2006-11-01 This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer after gastric bypass surgery.
NCT00674115 A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED) Completed Valeant Pharmaceuticals International, Inc. Phase 3 2008-04-01 Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.
NCT00674115 A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED) Completed Bayer Phase 3 2008-04-01 Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.
NCT00693225 Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study Completed Valeant Pharmaceuticals International, Inc. Phase 4 2008-01-01 The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.
NCT00693225 Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study Completed Yvonne Romero Phase 4 2008-01-01 The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.
NCT00765206 A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED) Completed Valeant Pharmaceuticals International, Inc. Phase 3 2008-05-01 Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.
NCT00765206 A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED) Completed Bayer Phase 3 2008-05-01 Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zegerid Otc

Condition Name

Condition Name for Zegerid Otc
Intervention Trials
Human Experimentation 2
Gastroesophageal Reflux 2
Gastric Acid 2
Barrett Esophagus 1
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Condition MeSH

Condition MeSH for Zegerid Otc
Intervention Trials
Gastroesophageal Reflux 3
Heartburn 2
Ulcer 1
Peptic Ulcer 1
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Clinical Trial Locations for Zegerid Otc

Trials by Country

Trials by Country for Zegerid Otc
Location Trials
United States 4
United Kingdom 1
Poland 1
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Trials by US State

Trials by US State for Zegerid Otc
Location Trials
California 1
Oklahoma 1
Minnesota 1
Missouri 1
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Clinical Trial Progress for Zegerid Otc

Clinical Trial Phase

Clinical Trial Phase for Zegerid Otc
Clinical Trial Phase Trials
Phase 4 3
Phase 3 4
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Zegerid Otc
Clinical Trial Phase Trials
Completed 8
Unknown status 2
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Clinical Trial Sponsors for Zegerid Otc

Sponsor Name

Sponsor Name for Zegerid Otc
Sponsor Trials
Bayer 4
Valeant Pharmaceuticals International, Inc. 3
Norgine 2
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Sponsor Type

Sponsor Type for Zegerid Otc
Sponsor Trials
Industry 10
Other 3
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